Fluvastatin Doc Generici

Patient Information Leaflet: Information for the User

FLUVASTATIN DOC Generics 80 mg prolonged-release tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What FLUVASTATIN DOC Generics is and what it is used for
2. What you need to know before taking FLUVASTATIN DOC Generics
3. How to take FLUVASTATIN DOC Generics
4. Possible side effects
5. How to store FLUVASTATIN DOC Generics
6. Contents of the pack and other information

1. What FLUVASTATINA DOC Generici is and what it is used for

FLUVASTATINA DOC Generici contains the active substance sodium fluvastatin, which belongs to a group of medicines known as statins, which are lipid-lowering agents: these medicines lower fats (lipids) in the blood. They are used in patients whose conditions cannot be controlled by diet and exercise alone.

• FLUVASTATINA DOC Generici is a medicine used to treat high levels of fats in the blood in adults, particularly total cholesterol and LDL cholesterol, also known as "bad" cholesterol, which is associated with an increased risk of heart disease and stroke.
• in adult patients with high blood cholesterol levels.
• in adult patients with high levels of cholesterol and triglycerides (another type of lipid) in the blood.
• Your doctor may also prescribe FLUVASTATINA DOC Generici to prevent further serious cardiac events (e.g., heart attack) in patients who have already undergone cardiac catheterization with an intervention on the heart vessels.

2. What you need to know before taking FLUVASTATINA DOC Generici

Follow carefully all your doctor's instructions. They may differ from the general information contained in this leaflet.
Before taking FLUVASTATINA DOC Generici, read the following information.

Do not take FLUVASTATINA DOC Generici

• if you are allergic to fluvastatin or to any of the other ingredients of this medicine (listed in section 6).
• if you currently have liver problems or have persistent and unexplained high levels of certain liver enzymes (transaminases).
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding"). If any of these conditions apply to you, do not take FLUVASTATINA DOC Generici and inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking FLUVASTATINA DOC Generici:

• if you have previously had liver disease. Liver function tests are usually performed before starting treatment with FLUVASTATINA DOC Generici, when the dose is increased, and at various intervals during treatment to monitor for adverse effects.
• if you have kidney disease.
• if you have a thyroid disorder (hypothyroidism).
• if you have or have a family history of muscle disorders.
• if you have experienced muscle problems with another lipid-lowering medicine.
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and FLUVASTATINA DOC Generici may lead to serious muscle problems (rhabdomyolysis).
• if you regularly consume large amounts of alcohol.
• if you have a severe infection.
• if you have very low blood pressure (symptoms may include dizziness, lightheadedness).
• if you engage in excessive physical exercise, whether controlled or uncontrolled.
• if you are about to undergo surgery.
• if you have severe metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes or low potassium levels in the blood. During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

Before taking FLUVASTATINA DOC Generici, check with your doctor or pharmacist:

• if you have severe respiratory insufficiency. If any of these conditions apply to you, inform your doctor before taking FLUVASTATINA DOC Generici. Your doctor will perform blood tests before prescribing FLUVASTATINA DOC Generici.

If, during treatment with FLUVASTATINA DOC Generici, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellowing of the eyes or skin, confusion, euphoria or depression, slowed thinking, difficulty speaking, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver failure. In this case, contact your doctor immediately.

Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be needed to diagnose and treat this condition.

Patients over 70 years

If you are over 70 years old, your doctor may want to assess whether you have risk factors for muscle disorders. You may require specific blood tests.

Children and adolescents

FLUVASTATINA DOC Generici has not been studied and should not be used in children under 9 years of age. For information on dosing in children and adolescents over 9 years of age, see section 3.

There is no experience with the use of FLUVASTATINA DOC Generici in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Other medicines and FLUVASTATINA DOC Generici

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. FLUVASTATINA DOC Generici can be taken alone or with other cholesterol-lowering medicines prescribed by your doctor.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart FLUVASTATINA DOC Generici. Taking FLUVASTATINA DOC Generici with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). Further information on rhabdomyolysis can be found in section 4.

After taking a resin such as cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking FLUVASTATINA DOC Generici.

Inform your doctor and pharmacist if you are taking any of the following medicines:

• Cyclosporine (a medicine used to reduce the activity of the immune system).
• Fibrates (e.g., gemfibrozil), nicotinic acid, or bile acid sequestrants (medicines used to lower levels of bad cholesterol).
• Fluconazole (a medicine used to treat fungal infections).
• Rifampicin (an antibiotic).
• Phenytoin (a medicine used to treat epilepsy).
• Oral anticoagulants such as warfarin (medicines used to reduce blood clotting).
• Glibenclamide (a medicine used to treat diabetes).
• Colchicine (used to treat gout).

FLUVASTATINA DOC Generici with food and drink

FLUVASTATINA DOC Generici can be taken with or without food.

Pregnancy and breastfeeding

Do not take FLUVASTATINA DOC Generici if you are pregnant or breastfeeding, as the active substance may be harmful to the fetus, and it is not known whether the active substance is excreted in breast milk. If you are pregnant, consult your doctor or pharmacist before taking FLUVASTATINA DOC Generici. Take appropriate precautions against pregnancy while taking FLUVASTATINA DOC Generici.

If pregnancy occurs while taking this medicine, stop taking FLUVASTATINA DOC Generici and contact your doctor.

Your doctor will discuss with you the potential risks of taking FLUVASTATINA DOC Generici during pregnancy.

Driving and using machines

There is no information available on the effects of FLUVASTATINA DOC Generici on the ability to drive vehicles or use machinery.

3. How to take FLUVASTATINA DOC Generici

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Do not exceed the recommended dose.
Your doctor will recommend that you follow a cholesterol-lowering diet. Continue this diet while taking FLUVASTATINA DOC Generici.

How much FLUVASTATINA DOC Generici to take

• For adults, the dose ranges from 20 to 80 mg daily, depending on the required degree of cholesterol reduction. Dose adjustments may be made by your doctor at 4-week intervals or longer.
• For children (9 years and older), the recommended starting dose is 20 mg daily. The maximum daily dose is 80 mg. Dose adjustments may be made by your doctor at 6-week intervals.

Your doctor will tell you exactly how many capsules or tablets to take.
Depending on your response to treatment, your doctor may recommend a higher or lower dose.

When to take FLUVASTATINA DOC Generici
You may take the dose at any time of day.
FLUVASTATINA DOC Generici may be taken with or without food. Swallow the tablet whole with a glass of water.
FLUVASTATINA DOC Generici 80 mg prolonged-release tablets are not suitable for initiating treatment; for this purpose, other pharmaceutical forms and doses (20 and 40 mg) are appropriate.

If you take more FLUVASTATINA DOC Generici than you should
If you accidentally take too much FLUVASTATINA DOC Generici, inform your doctor immediately. You may require medical treatment.

If you forget to take FLUVASTATINA DOC Generici
Take the missed dose as soon as you remember. However, do not take it if less than 4 hours remain before the next scheduled dose.
In this case, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking FLUVASTATINA DOC Generici
To maintain the benefits of treatment, do not stop taking FLUVASTATINA DOC Generici unless instructed by your doctor. You should continue taking FLUVASTATINA DOC Generici as prescribed to keep your "bad" cholesterol levels low.
FLUVASTATINA DOC Generici does not cure the condition but helps to control it. Cholesterol levels need to be regularly monitored to assess improvement. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some rare or very rare side effects can be serious: seek immediate medical attention if they occur.

• if you have unexplained muscle pain, tenderness to touch, or weakness. These could be early signs of potentially severe muscle breakdown. This can be prevented if your doctor stops treatment with fluvastatin as soon as possible. These side effects have also been reported with similar medicines in this class (statins).
• if you experience unexplained tiredness or fever, yellowing of the skin or eyes, dark-coloured urine (signs of hepatitis).
• if you develop signs of skin reactions such as rash, hives, redness, itching, swelling of the face, eyelids, or lips.
• if you have skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).
• if you bleed or bruise more easily than normal (signs of reduced platelet count in the blood).
• if you have red or purple skin lesions (signs of blood vessel inflammation).
• if you develop red spots on the skin, especially on the face, possibly accompanied by tiredness, fever, nausea, loss of appetite (signs of a lupus-like reaction).
• if you have severe pain in the upper abdomen (signs of pancreas inflammation). If you experience any of these effects, contact your doctor immediately.

Other side effects: contact your doctor if they concern you.
Common (may affect up to 1 in 10 people):
Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, abnormal results in blood tests for muscle and liver.
Very rare (may affect up to 1 in 10,000 people):
Tingling or numbness in the hands or feet, altered or reduced sensation.
Frequency not known (frequency cannot be estimated from the available data):
Impotence.
Persistent muscle weakness.
Diarrhoea.
Other possible side effects

• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual difficulties
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever.

Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FLUVASTATIN DOC Generici

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C. Store in the original packaging to protect the medicine from light.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FLUVASTATINA DOC Generici contains

• The active substance is: fluvastatin as fluvastatin sodium. Each prolonged-release tablet of FLUVASTATINA DOC Generici 80 mg contains 84.48 mg of fluvastatin sodium, equivalent to 80 mg of free acid fluvastatin.
• The other components are:
  Tablet core: povidone, microcrystalline cellulose, hydroxyethyl cellulose, mannitol, magnesium stearate.
  Film coating: hypromellose 50, macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).

Description of the appearance of FLUVASTATINA DOC Generici and pack sizes
FLUVASTATINA DOC Generici prolonged-release tablets are yellow, round, biconvex.
Pack sizes:
Blister (OPA/Alu/PVC-Alu): 14 and 28 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturer
Actavis hf.
Reykjavikurvegi 78,
IS-222 Hafnarfjordur
Iceland
Actavis Ltd.
BLB016 Bulebel Industrial Estate,
Zejtun ZTN 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Fluvastatin DOC Generici
Italy: FLUVASTATINA DOC Generici